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Blood Flow Restriction Training in Pre-frail and Frail Older Adults

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Blood flow restriction resistance training
Resistance training
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Blood flow restriction, Resistance exercise, Frailty

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged over 60 years old
  • Fried frailty index fulfill 1-2 criteria
  • Able to walk 6 meters independently
  • Able to understand and follow ≥ 3 instructions

Exclusion Criteria:

  • Severe hypertension (>180/110mmHg)
  • Peripheral neuropathy
  • History of deep-vein thrombosis (DVT)
  • Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
  • Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
  • History of resisted exercise training program within the last 6 months before screening

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood flow restriction resistance training

Resistance training

Arm Description

Outcomes

Primary Outcome Measures

Change of muscle strength of the lower extremities
Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
Change of 30 seconds sit to stand
30 seconds sit to stand
Change of timed-up-and-go test
Timed-up-and-go test

Secondary Outcome Measures

Change of one-repetition maximum
One-repetition maximum of step-ups
Change of muscle mass
Muscle mass of the upper and lower extremities and trunk
Change of hand grip
Bilateral hand grip strength
Change of physical activity level
The International Physical Activity Questionnaire (IPAQ)

Full Information

First Posted
August 4, 2020
Last Updated
January 10, 2022
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04507152
Brief Title
Blood Flow Restriction Training in Pre-frail and Frail Older Adults
Official Title
Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Blood flow restriction, Resistance exercise, Frailty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood flow restriction resistance training
Arm Type
Experimental
Arm Title
Resistance training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Blood flow restriction resistance training
Intervention Description
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.
Primary Outcome Measure Information:
Title
Change of muscle strength of the lower extremities
Description
Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Title
Change of 30 seconds sit to stand
Description
30 seconds sit to stand
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Title
Change of timed-up-and-go test
Description
Timed-up-and-go test
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Secondary Outcome Measure Information:
Title
Change of one-repetition maximum
Description
One-repetition maximum of step-ups
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Title
Change of muscle mass
Description
Muscle mass of the upper and lower extremities and trunk
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Title
Change of hand grip
Description
Bilateral hand grip strength
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups
Title
Change of physical activity level
Description
The International Physical Activity Questionnaire (IPAQ)
Time Frame
Before training, 3 and 6 weeks after training, and one and two months follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 60 years old Fried frailty index fulfill 1-2 criteria Able to walk 6 meters independently Able to understand and follow ≥ 3 instructions Exclusion Criteria: Severe hypertension (>180/110mmHg) Peripheral neuropathy History of deep-vein thrombosis (DVT) Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis) Neuromuscular diseases (i.e. Stroke, Parkinsons' disease) History of resisted exercise training program within the last 6 months before screening
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan city
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restriction Training in Pre-frail and Frail Older Adults

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